PROJECT PLAN FALL 2008 ADVISOR : PHILIP TROYK I P R O 3 0 6 Planning for Human Implantation of a Cortical Visual Prothesis 1.0 Abstract Over the years there has been intensive research on visual prosthesis around the world and significant technological advancements have been made. The Intracortical Visual Prosthesis Team (IVP) at IIT has been researching and devel- oping a procedure as well as a device which will be implanted within the human visual cortex. The device consists of sub-miniature electrodes which will artifi- cially stimulate the visual cortex by introducing electrical currents in to the cor- tex. The IIT Team has reached a point in their 10 year development process where they would like to proceed with implanting the device in a volunteer in the next few years. Implantation of a device which provides artificial vision is an extraordinarily complex process. In the initial stages the medical and engineering aspects are the most prevalent ones, but as the project moves forward there are some questions that inevitably must be answered or at least considered. These questions deal much less with the technology and much more with the volunteers that will eventually have these complex devices implanted. To try and answer some of these questions, in IPRO 306 we will look into various medical, political, engi- neering, ethical, media and psychological issues that we believe may become of greater importance as the project progresses into the implementation stage. We will also look into the public relations aspect as well as some political and psy- chological issues. Based on our research and understanding we will provide several issues that we see as needing to be addressed in the future and recom- mend possible solutions to them. 2.0 BACKGROUND A. This IPRO project is sponsored by the Intracortical Visual Prosthesis Team at IIT, which includes the University of Chicago, Huntington Medical Research Institutes in Pasadena, CA, EIC Laboratories in Norwood, MA, and Micro Probe Inc in Frederick Maryland. B. The goal of the IPRO team is to create a project road map that will de- tail the needs and requirements needed to meet the criteria of safety for an implanted prosthesis. C. Visual prosthetics have been implanted in patients around the world both acutely and chronically. The major types of visual prosthesis involve interfacing at the retina, the optic nerve or in this case the visual cortex. Despite attempts with varying results, a demonstration of a device with the required degree of performance has not yet been made. Although en- gineering an device such as the intracortical implant would be a great achievement and a great feat of engineering, it will not do much good un- less all other political, ethical, moral and medical issues are accounted for, so that it will more easily be accepted by the public with the least, if any, negative impact on the volunteers or society. D. This IPRO is the first of its kind. No previous IPRO has explored the various moral, ethical, cultural or scientific issues of implanting a hu- man with a visual prosthesis. E. The IIT Institutional Review Board (IRB) is responsible for reviewing all research involving humans in any way, and deciding whether all involvement with humans is done within strict guidelines, which take into account ethnical, medical, moral and cultural issues. Before any such testing may be done the IRB must approve it. We will review the ethical, medical, cultural, and moral issues and provide our own opin- ion on whether this device is ready for human implantation, and what may be some possible issues that can arise as the project moves into the implantation stage. F. No additional documents will be attached with the project plan. 3.0 OBJECTIVES •! Review available literature on visual prosthetics, focusing on intracortical, and make an assessment on the status of this technology. •! Expand on the ethical, psychological, medical, regulatory, political, media, and engineering aspects of this new technology. • Make inferences regarding the overall effects of the multispectral aspects of Intracortical Visual Prosthetics on human volunteers, and create a plan bridging the gap between the current state of the technology and the point of the first human volun- teer. 4.0 METHODOLOGY A. Work Structure Breakdowns B. Problems: In order to establish a road map toward the implantation of a visual prosthesis, it would be helpful to highlight some important questions that we wish to cover: !" What medical issues can we expect from a brain implant? !" Is the technology advanced enough to successfully install the device? !" What criteria should be considered during the selection process of the volunteers? !" What should the selected volunteers expect? !" How should we educate the public? B. Problems: In order to establish a road map toward the implantation of a visual prosthesis, it would be help- ful to highlight some important questions that we wish to cover: !" What medical issues can we expect from a brain implant? !" Is the technology advanced enough to successfully install the device? !" What criteria should be considered during the selection process of the volunteers? !" What should the selected volunteers expect? !" How should we educate the public? C. Plan of Attack: ! Since this is the first time we are doing this project and all of the team members come from different backgrounds , we divided the project into two phases. During Phase 1 which is research phase. All members are expected to raise the knowledge lev- els on the topic during this phase. We divide into seven sub teams and assigned tasks to individuals. iGroups has been organized so team members can upload files to relevant folders. often interact with each other so everyone will be at the same level of under- standing. We will also participate in real life interaction (visiting laboratories and the Chicago Lighthouse, interviewing people involved in the project). We will have a midterm regroups and move forward to Phase 2. At this phase , we will compile the findings of each subgroup; discuss issues raised along Research and start to develop our thoughts on how to attack each issue. In the end of the project we will be able to come up with a list of what are still left to be done and what can be done now for the preparation of the first Human implantation. D. Possible Outcomes: ! By the end of the project, all members are expected to gain knowledge on the topic. Due to the open ended nature of the topic at hand and because of the different factors involved in this evaluation, the team may conclude that the device could or could not safely be tested on human beings. In any case, we will try to provide justifica- tions regarding our final opinion on the subject. E. GANTT CHART E. GANTT CHART ! ! 5.0 BUDGET ITEMS COST EXPLANATION Out of Class meeting $250 To thank guests for visits since the members Cortical Visual Prosthetics is located all over the united states and Team building dinner and snacks for out of class dinner. Airline Tickets for 2 to Baltimore $1,200 To look at labs to see if they meet FDA standards and to see ask question about the engineering of this devices Office supplies $50 Binders and dividers to store paper work Total $1,500 ! 6.0 TEAM STRUCTURE AND ASSIGNMENTS A. TEAM MEMBER MAJOR / YEAR SKILLS/STRENGTH EXPERIENCES/ ACADEMIC INTER- ESTS TEAM(S) Andrew Rust Biology/Senior Computing. carpentry. research Botany, Marine biology Medical & Politics Dan Tian Biomedical Engi- neering/ Senior Basic computer skills Lab research (wet lab)/ Research in biomedical Engineering Media Joel Kam Sadja Electrical Engi- neering Java, Solid Edge, AutoCad, Ms Office Super conductors, Shock resistant ceramics Ethics & Poli- tics Josh Blackketter Materials Engi- neering/ Senior Editing/Proofreading, Re- search, Materials Micrography Material Interfaces Psychology Kevin Ragauskis Biomedical Enigeeering/ Junior Computer hardware, basic hardware diagnostics, Expan- sive knowledge of Library da- tabase systems 33rd Street Productions, Ipro 310 - Assisted devices for Blind and Visual Im- paired swimmers, Viola music, Runs simply strings quartet out of Orland Park Ethics/Team leader Marin Assaliyski Aerospace and Mechanical Engineering / Junior Great team skills. Reliable and on time Operating X Ray equip- ment, Security checkpoint coordinator, Long way backscatter. O’Hare secu- rity Inspector Medical Minh Tran Chemical Engineering/ Senior Engineering skills , team work, Research 2 years working experi- ences + 2 IPRO experi- ences. Interest : Renewable Energy , Environmental Regulation Engineer & Regulation Peter Mathes Psychology/ Senior Focused, experience in different disciplines, cultured. Focused, experience in different disciplines, cul- tured. Psychology ! TEAM MEMBER MAJOR / YEAR SKILLS/STRENGTH EXPERIENCES/ ACADEMIC INTER- ESTS TEAM(S) Saurabh Jain Electrical and Computer Engineering/ Senior Micro assembly, Microproces- sor, solder, debugging circuits. Electronics, Machining, elec- tronics, wire bonding, AutoCad, Assembly language, Java & C + Researched for the Ad- vanced commutation Laboratory at IIT, Engineering Tech at Sigenics Regulation & Engineer Figure 1 - Team roster B. Our team has decided to have seven sub-teams to help cover all the different topics dealing with implantation of a device into the human body. Our sub teams are medical, politics, ethics, engi- neering, media, regulatory and psychology team. We do not have sub team leaders because we only have one or two members in each team. SUB TEAM MEMBERS TASKS Engineering Minh Tran & Saurabh Jain Look at Previous Technology, Un- derstand the intracortical Prosthet- ics, Figure out the Fundamental requirements, Visit IIT Neuro Lab, Collect data from previous experi- ments, Identify pros and cons of Devices and determine if the de- vices is read for human trials, iden- tify all the material used on the chip. Ethics Kevin Ragauskis Identify all ethical problems, safety issues, determine the right type of test subject, Risks vs Benefits, de- termine inform of consents. Media Dan Tian Marketing, educating the public on the facts of the new technology Medical Marin Assaliyski & Andrew Rust Identify risk associated the devices, and get background data. Need to look at pre- clinical datas and study previous Animal testing to deter- mine if this device is ready for trials on Human volunteers Psychology Peter Mathes & Josh Blackketter Identify Psychological effects , kinds of vision blind people want to restore Politics Joel Kam Sadja & Andrew Rust Assessment on how outsiders feel about this type of technology and determine how to handle public ‘s reactions about the new technology Regulatory Minh Tran & Saurabh Jain Review previous submitted docu- ments to the FDA for other implan- tation devices, identify steps needed to have a new regulation. ! SUB TEAM MEMBERS TASKS Engineering Minh Tran & Saurabh Jain Look at Previous Technology, Un- derstand the intracortical Prosthet- ics, Figure out the Fundamental requirements, Visit IIT Neuro Lab, Collect data from previous experi- ments, Identify pros and cons of Devices and determine if the de- vices is read for human trials, iden- tify all the material used on the chip. Ethics Kevin Ragauskis Identify all ethical problems, safety issues, determine the right type of test subject, Risks vs Benefits, de- termine inform of consents. Media Dan Tian Marketing, educating the public on the facts of the new technology Medical Marin Assaliyski & Andrew Rust Identify risk associated the devices, and get background data. Need to look at pre- clinical datas and study previous Animal testing to deter- mine if this device is ready for trials on Human volunteers Psychology Peter Mathes & Josh Blackketter Identify Psychological effects , kinds of vision blind people want to restore Politics Joel Kam Sadja & Andrew Rust Assessment on how outsiders feel about this type of technology and determine how to handle public ‘s reactions about the new technology Regulatory Minh Tran & Saurabh Jain Review previous submitted docu- ments to the FDA for other implan- tation devices, identify steps needed to have a new regulation. Figure 2- Team structure ! C. TASK TEAM MEMBER Minute taker Dan Tian Agenda Maker Kevin Ragauskis Time Keeper Kevin Ragauskis Weekly timesheet collector/ Sum- marizer Marin Assaliyski Master schedule maker Saurabh Jain iGroups Dan Tian Figure 3 - Team project monitoring roles D. ! ! Figure 4- Master schedule - part 1 of 2 ! Figure 5- Master schedule - part 2 of 2 !